PTSD Clinical Trial
— TSOS 8Official title:
A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems
This investigation is a randomized pragmatic trial of a brief stepped care intervention delivered from an acute care medical trauma center that may both reduce the symptoms of posttraumatic stress disorder (PTSD) and diminish emergency department health service utilization.
Status | Recruiting |
Enrollment | 424 |
Est. completion date | October 31, 2027 |
Est. primary completion date | July 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Injured patients =18 years of age - Meet = 3 of 10 risk domain criteria in electronic health records (EHR) screen - Score of = 30 on DSM-5 PTSD Checklist (PCL) score or score of = 35 on DSM-IV PTSD Checklist (PCL) . - Speak English and/or Spanish Exclusion Criteria: - Age <18 - Not admitted for a traumatic injury - Speak a language other than English and/or Spanish - Acutely suicidal/admitted for a suicide attempt - Cognitively impaired - Incarcerated - Acutely psychotic - Not a resident of Washington, California, Alaska, Oregon, Idaho, Montana, or Nevada - Less than 2 pieces of contact information - Prior history of violence, such that study staff may not be safe - Patient with overwhelming psychiatric distress and not advisable/will not tolerate randomization to control condition - Most recent COVID-19 test positive |
Country | Name | City | State |
---|---|---|---|
United States | Harborview Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Posttraumatic Stress Disorder (PTSD) symptoms change over time | The investigators will use the DSM-5 PTSD Checklist (PCL-5) and DSM-IV PTSD Checklist (PCL-IV). The scoring of the PCL-5 scale ranges from a minimum of 0 to a maximum of 80, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD. | Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up | |
Primary | Emergency department utilization change over time | Number of emergency visits will be assessed using the Emergency Department Information Exchange (EDIE). More emergency visits are indicative of a worse outcome. | Baseline injury admission to 12-months post-injury follow-up | |
Secondary | Alcohol use change over time | The investigators will use the Alcohol Use Disorders Identification Test - Concise (AUDIT-C) measure. The 3-item scale score ranges from 0-12, with higher values indicating a worse outcome. | Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up | |
Secondary | Mental and physical functioning change over time | The Medical Outcomes Study Short Form healthy survey (SF-12) will be used as a continuous measure. The 12-item scale score ranges from 0-100, with higher scores representing a better outcome. The two summary measures, Physical Component Summary (PCS) and Mental Component Summary (MCS), will be scored. | Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up | |
Secondary | Depression symptoms change over time | The Patient Health Questionnaire 9-item Depression Scale (PHQ-9) will be used to assess symptoms of depression. The scoring of the scale ranges from 0-27, with higher scores indicating a worse outcome. The scale can also be dichotomized to indicate depressive symptom cutoffs and DSM depressive disorder criteria. | Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up | |
Secondary | Suicide risk assessment change over time | The Columbia Suicide Severity Rating Scale (CSSRS) is a 6-item questionnaire to assess risk of suicide. The scoring of the scale ranges from 2-25, with higher scores indicating a worse outcome. | Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up | |
Secondary | Substance use change over time | Single items self report that assesses opioid use, amphetamines, cocaine and marijuana. Single item self-report are categorically rated from no use to use four or more times a week. | Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03962504 -
Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial
|
N/A | |
Completed |
NCT01995123 -
Behavioral Activation for Smoking Cessation in PTSD
|
N/A | |
Not yet recruiting |
NCT06278922 -
Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma
|
N/A | |
Completed |
NCT04597450 -
Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)
|
Phase 1 | |
Completed |
NCT03593772 -
Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD
|
N/A | |
Completed |
NCT03429166 -
Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas
|
N/A | |
Recruiting |
NCT04317820 -
Deep Brain Reorienting in Post-traumatic Stress Disorder
|
N/A | |
Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
Completed |
NCT03504722 -
Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD
|
N/A | |
Completed |
NCT04305353 -
Intensive Care Unit (ICU) Diary Project
|
N/A | |
Completed |
NCT03113890 -
McLean and Genomind Prospective Study
|
N/A | |
Withdrawn |
NCT05173831 -
Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans
|
Phase 2 | |
Not yet recruiting |
NCT04056767 -
Changes in Digital Phenotype During PE Therapy
|
||
Withdrawn |
NCT03924297 -
Chilipad for Sleep and Symptoms of PTSD
|
N/A | |
Withdrawn |
NCT03216356 -
Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD
|
Phase 2/Phase 3 | |
Completed |
NCT03343028 -
Biomarker Establishment for Superior Treatment of PTSD
|
||
Completed |
NCT03158558 -
Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD
|
N/A | |
Completed |
NCT02370173 -
A Non-Pharmacological Method for Enhancing Sleep in PTSD
|
N/A | |
Completed |
NCT01955538 -
The Effect of BAT Versus Mixed Physical Activity as add-on Treatment for Traumatised Refugees.
|
Phase 3 | |
Completed |
NCT01911585 -
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
|
N/A |